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Data / Medical devices / Camera, Scintillation (Gamma)

Camera, Scintillation (Gamma) (IYX): 17 FDA-registered makers in 7 countries

17 establishments in 7 countries are registered with the FDA to make Camera, Scintillation (Gamma) (product code IYX, Class 1, 21 CFR 892.1100). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 130 510(k) clearances under this code, the latest on August 28, 2023, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
IYX
Device class
1
Regulation
892.1100
Medical specialty
Radiology

Makers by country

CountryMakers
United States9
Israel2
Germany2
Spain1
Sweden1
Canada1
Thailand1

Makers of Camera, Scintillation (Gamma)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CMR Naviscan CorporationCarlsbad, CA, United StatesManufacturer2September 23, 2011000api.fda.gov
Digirad Diagnostic Imaging, LLCPoway, CA, United StatesManufacturer2January 15, 2013000api.fda.gov
Ge Medical Systems Israel, Functional ImagingTIRAT HACARMEL Haifa, IsraelManufacturer2November 18, 2016010api.fda.gov
Ge Medical Systems Israel, Functional ImagingHaifa, IsraelSpecification developer2November 18, 2016000api.fda.gov
General Equipment For Medical Imaging, S.A.Valencia Valencia(Province), SpainManufacturer2August 18, 2016000api.fda.gov
Hermes Medical Solutions, ABStockholm, SwedenComplaint file establishment, Manufacturer1July 19, 2017000api.fda.gov
Hologic, Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer1September 13, 2006000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1November 24, 1993000api.fda.gov
Radiopharmaceutical Imaging & Dosimetry, LLCBaltimore, MD, United StatesManufacturer1February 22, 2023000api.fda.gov
Smartbreast Corporation, Inc.Sherman Oaks, CA, United StatesComplaint file establishment, Specification developer1November 3, 2010000api.fda.gov
Convergent Imaging SolutionsOttawa Ontario, CanadaManufacturer0000api.fda.gov
Foamtec International Co., Ltd.Sriracha Chon Buri, ThailandContract manufacturer0000api.fda.gov
Inter Medical Medizintechnik GMBHLUEBBECKE North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Mie GMBHSETH Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Mim Software Inc.Cleveland, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Sonomed, Inc.Westbury, NY, United StatesManufacturer0000api.fda.gov
UFP Technologies, Inc.Compton, CA, United StatesContract manufacturer0000api.fda.gov

Updated August 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.